PregnancyNCT02430246
The Association Between the Transfer of Lactobacilli From the Gastrointestinal Tract to the Vagina and the Prevention / Eradication of Abnormal Vaginal Flora in High Risk Pregnancies
A study testing Urex Plus and Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 in people with Pregnancy, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV) by taking vaginal smear. Treatment will be given according to the results. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Urex Plus and Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women from at least 13 weeks of gestation with a risk factor for preterm labor
Who cannot join
- Women with preterm premature rupture of the membranes
- Immunocompromised women
- Planned elective preterm birth for reasons other than preterm premature rupture of membranes
Trial locations and contacts
1 site in 1 country.
About this study
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV) by taking vaginal smear. Treatment will be given according to the results.
Read the detailed description
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect AVF/BV by taking vaginal smear. Diagnosis will be according to the Nugent score criteria. Treatment will be given according to the results:
Patient with a positive smear for AVF- patients tested positive will be treated with either clindamycin or metronidazole. Following treatment another smear will be taken according to which the patients will be divided into 2 research groups: (1) Assessing the effectiveness of probiotic formula to prevent AVF re-infection (secondary infection) - this group includes patients with normal vaginal flora following antibiotic administration. (2) Assessing the effectiveness of probiotic formula to eradicate AVF - this group includes patients with persistent AVF following antibiotic administration (first and second line). In each group the patients will be divided into a research group which will receive the probiotic formula UREX PLUS (containing L. rhamnosus GR-1and L. reuteri RC-14) and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.
Patient with a negative smear for AVF - in those patients the effectiveness of probiotic formula will be tested for primary prevention. These patients will be divided into a research group which will receive the probiotic formula UREX PLUS and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.
Finally, the colonization of lactobacilli in the vaginal flora will be examined by dividing patients with normal vaginal flora into one group receiving a probiotic capsule containing L. rhamnosus GR-1 and L. reuteri RC-14 twice a day for 2 months and a second group without intervention. After two months the group receiving probiotic capsule will receive no treatment and the second group will receive probiotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 twice a day for 2 months.
- Conditions
- Pregnancy
- Being tested
- Urex Plus, Placebo, Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urex PlusDietary supplement
Probiotic
PlaceboOther
capsule without active ingredient
Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Primary prevention - Urex Plus | Experimental | Patients with Normal vaginal flora in the experimental arm will be treated with UREX PLUS Receives: Dietary Supplement: Urex Plus |
| Primary prevention - Placebo | Placebo comparator | Patients with Normal vaginal flora in the Placebo arm will be treated with a capsule without active ingredient Receives: Other: Placebo |
| Secondary prevention - Urex Plus | Experimental | Patients with abnormal vaginal flora in the experimental arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given UREX PLUS Receives: Dietary Supplement: Urex Plus |
| Secondary prevention - Placebo | Placebo comparator | Patients with abnormal vaginal flora in the Placebo arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given placebo without active ingredient Receives: Other: Placebo |
| Eradication - Urex Plus | Experimental | Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the experimental arm will be treated with UREX PLUS Receives: Dietary Supplement: Urex Plus |
| Eradication - Placebo | Placebo comparator | Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the placebo arm will be treated with placebo without active ingredient Receives: Other: Placebo |
| Lactobacilli transfer - probiotic capsule | Other | Patients with Normal vaginal flora will be treated with a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months afterwhich they will receive no treatment for additional two months. Lactobacili colonization in the vaginal flora will be tested Receives: Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 |
| Lactobacilli transfer - probiotic capsule after 2 months | Other | Patients with Normal vaginal flora will be followed for two months without intervention afterwhich they will receive a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months. Lactobacili colonization in the vaginal flora will be tested. Receives: Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of lactobacilli in the vaginal
Lactobacilli culture will be made from a vaginal specimen. The pattern of bacterial growth will be used for a semi-quantitative interpretation in a scale of 0-no vaginal colonization to 4-substantial colonization.
Measured: once a month until week 36.6 of labor
The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period
Measured: From date of randomization until the date of first documented episode or until delivery (around 4 months)
The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period
Measured: From date of randomization until the date of first documented episode or until delivery (around 4 months)
The rate of women with AVF/BV at enrollment whose infection was not eradicated following antibiotics, who restored the normal vaginal flora during the study period
Measured: Until delivery (around 4 months)
Secondary outcomes (5)
Duration of time from the beginning of the study until an episode of AVF/BV
Measured: From date of randomization until the date of first documented episode or until delivery (around 4 months)
The number of episodes of BV/AVF during pregnancy
Measured: Until delivery (around 4 months)
The rate of women, who suffer from obstetrical outcomes(preterm labor, intrauterine growth restriction, preterm premature rupture of membranes, chorioamnionitis, post-partum fever, post-partum endometritis, neonatal sepsis and neonatal complications)
Measured: Until delivery (around 4 months)
The rate and type of adverse effects in the probiotic versus placebo groups
Measured: Until delivery (around 4 months)
Number of urinary tract infections during the study period
Measured: Until delivery (around 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJan 2016
- Primary completion14 Mar 2017
- Study completion10 Jan 2019
Why it stopped: After completing the part of assessing lactobacilli transfer, it was decided not to proceed further with the masked part of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enav yefet, HaEmek Medical Center, Israel
- Investigators
- ENAV YEFET, MD/PhD, Principal investigator, HaEmek Medical Center , Afula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430246
- Sponsor's protocol ID
- 0096-13
- Status last verified
- Dec 2019
- First submitted
- 20 Apr 2015
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between the Transfer of Lactobacilli From the Gastrointestinal Tract to the Vagina and the Prevention / Eradication of Abnormal Vaginal Flora in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT02430246
- Acronym / sponsor ID
- 0096-13
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After completing the part of assessing lactobacilli transfer, it was decided not to proceed further with the masked part of the study.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV) by taking vaginal smear. Treatment will be given according to the results.
Detailed description
Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect AVF/BV by taking vaginal smear. Diagnosis will be according to the Nugent score criteria. Treatment will be given according to the results:
Patient with a positive smear for AVF- patients tested positive will be treated with either clindamycin or metronidazole. Following treatment another smear will be taken according to which the patients will be divided into 2 research groups: (1) Assessing the effectiveness of probiotic formula to prevent AVF re-infection (secondary infection) - this group includes patients with normal vaginal flora following antibiotic administration. (2) Assessing the effectiveness of probiotic formula to eradicate AVF - this group includes patients with persistent AVF following antibiotic administration (first and second line). In each group the patients will be divided into a research group which will receive the probiotic formula UREX PLUS (containing L. rhamnosus GR-1and L. reuteri RC-14) and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.
Patient with a negative smear for AVF - in those patients the effectiveness of probiotic formula will be tested for primary prevention. These patients will be divided into a research group which will receive the probiotic formula UREX PLUS and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.
Finally, the colonization of lactobacilli in the vaginal flora will be examined by dividing patients with normal vaginal flora into one group receiving a probiotic capsule containing L. rhamnosus GR-1 and L. reuteri RC-14 twice a day for 2 months and a second group without intervention. After two months the group receiving probiotic capsule will receive no treatment and the second group will receive probiotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 twice a day for 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Primary prevention - Urex Plus | Experimental | Dietary Supplement: Urex PlusPatients with Normal vaginal flora in the experimental arm will be treated with UREX PLUS |
| Primary prevention - Placebo | Placebo comparator | Other: PlaceboPatients with Normal vaginal flora in the Placebo arm will be treated with a capsule without active ingredient |
| Secondary prevention - Urex Plus | Experimental | Dietary Supplement: Urex PlusPatients with abnormal vaginal flora in the experimental arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given UREX PLUS |
| Secondary prevention - Placebo | Placebo comparator | Other: PlaceboPatients with abnormal vaginal flora in the Placebo arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given placebo without active ingredient |
| Eradication - Urex Plus | Experimental | Dietary Supplement: Urex PlusPatients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the experimental arm will be treated with UREX PLUS |
| Eradication - Placebo | Placebo comparator | Other: PlaceboPatients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the placebo arm will be treated with placebo without active ingredient |
| Lactobacilli transfer - probiotic capsule | Other | Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14Patients with Normal vaginal flora will be treated with a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months afterwhich they will receive no treatment for additional two months. Lactobacili colonization in the vaginal flora will be tested |
| Lactobacilli transfer - probiotic capsule after 2 months | Other | Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14Patients with Normal vaginal flora will be followed for two months without intervention afterwhich they will receive a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months. Lactobacili colonization in the vaginal flora will be tested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women from at least 13 weeks of gestation with a risk factor for preterm labor
Key exclusion criteria (3 listed)
- Women with preterm premature rupture of the membranes
- Immunocompromised women
- Planned elective preterm birth for reasons other than preterm premature rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urex PlusProbiotic | Dietary supplement | Eradication - Urex Plus, Primary prevention - Urex Plus, Secondary prevention - Urex Plus |
| Placebocapsule without active ingredient | Other | Eradication - Placebo, Primary prevention - Placebo, Secondary prevention - Placebo |
| Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 | Dietary supplement | Lactobacilli transfer - probiotic capsule, Lactobacilli transfer - probiotic capsule after 2 months |
Primary outcome
The amount of lactobacilli in the vaginal
Time frame: once a month until week 36.6 of labor
Lactobacilli culture will be made from a vaginal specimen. The pattern of bacterial growth will be used for a semi-quantitative interpretation in a scale of 0-no vaginal colonization to 4-substantial colonization.
The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period
Time frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period
Time frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
The rate of women with AVF/BV at enrollment whose infection was not eradicated following antibiotics, who restored the normal vaginal flora during the study period
Time frame: Until delivery (around 4 months)
5 secondary outcomes
Duration of time from the beginning of the study until an episode of AVF/BV
Time frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
The number of episodes of BV/AVF during pregnancy
Time frame: Until delivery (around 4 months)
The rate of women, who suffer from obstetrical outcomes(preterm labor, intrauterine growth restriction, preterm premature rupture of membranes, chorioamnionitis, post-partum fever, post-partum endometritis, neonatal sepsis and neonatal complications)
Time frame: Until delivery (around 4 months)
The rate and type of adverse effects in the probiotic versus placebo groups
Time frame: Until delivery (around 4 months)
Number of urinary tract infections during the study period
Time frame: Until delivery (around 4 months)
Results and safety
The study was stopped early (reason given: After completing the part of assessing lactobacilli transfer, it was decided not to proceed further with the masked part of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ENAV YEFET, MD/PhD principal investigator
HaEmek Medical Center , Afula
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urex Plus and Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 in people with Pregnancy, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After completing the part of assessing lactobacilli transfer, it was decided not to proceed further with the masked part of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of lactobacilli in the vaginal (time frame: once a month until week 36.6 of labor). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.